MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number REPLY DR

Device Problems Failure to Transmit Record (1521); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 04/29/2016

Event Type  Injury  

Event Description

Reportedly, during a followed up performed on (b)(6) 2016, it was noticed that there were no ventricular egms during sensing and threshold tests.

Manufacturer Narrative

Preliminary analysis of the available data showed that the reported event is due to an issue in dma (direct memory access) part of the device.In addition, the event previously reported for this device (refer to 1000165971- 2014 - 00602) was also due to an issue in dma part (same root cause).

Event Description

Reportedly, during a followed up performed on (b)(6) 2016, it was noticed that there were no ventricular egms during sensing and threshold tests.

Manufacturer Narrative

Please refer to the attached analysis report.

Event Description

Reportedly, during a followed up performed on (b)(6) 2016, it was noticed that there were no ventricular egms during sensing and threshold tests.

• Brand Name: REPLY
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L. - CRM FACILITY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer (Section G): SORIN GROUP ITALIA SRL VIA CRESCENTINO 13040 SALUGGIA ITALY; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140
• Manufacturer Contact: elodie vincent ; parc d'affaires noveos 4 avenue réaumur; .; clamart 92140 ; FR 92140 ; 0146013665
• MDR Report Key: 5706667
• MDR Text Key: 46818759
• Report Number: 1000165971-2016-00338
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: PP950029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2012
• Device Model Number: REPLY DR
• Device Catalogue Number: REPLY DR
• Device Lot Number: 2516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/13/2016
• Event Location: Hospital
• Date Manufacturer Received: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention